A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls

United Lincolnshire Hospitals NHS Trust

Status: Completed

Conditions: Rupture of Anterior Cruciate Ligament

Treatments: Procedure: Surgeons knowledge of pre-operative PBIs

Study type: Interventional

Funder types: Other

Identifiers

NCT02300012

120614Mullineaux

Details and patient eligibility

About

Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.

Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers in other conditions are sensitive in distinguishing between disease state severities, type of injuries and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not widely used possibly owing to their focus postoperatively where benefits are less worthwhile.

This study aims to investigate novel biomarkers as performance based investigations (PBIs) to improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The objectives are to identify whether biomarkers, collected before and after operations, can: 1) Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further understand ACL injuries.

Enrollment: 8 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• unilateral ACL rupture
• 18 - 45 years old

Exclusion criteria

• combined posterior and ACL rupture
• multi-ligament instability including medial or lateral collateral ligament injury
• other lower limb surgery <3mths
• current significant acute injury affecting other lower extremity joints, or other relevant neurological or musculoskeletal pathology.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

Operation - No PBI

No Intervention group

Description:

Patients requiring operation - baseline PBI data not seen by surgeon

Operation - PBI available

Experimental group

Description:

Patients requiring operation - baseline PBI data seen by surgeon pre-operatively

Treatment:

Procedure: Surgeons knowledge of pre-operative PBIs

Non-operation

No Intervention group

Description:

Patients with ACL rupture not requiring operation

Control

No Intervention group

Description:

Healthy age matched volunteers - No operation